Recall Z-2466-2012 ยท FNL Bed, Ac-Powered Adjustable Hospital
KCI USA, Inc.
BariAir Therapy System The BariAir Therapy System is a risk management treatment system designed for large and / or difficult-to-manage patients. The BariAir Therapy System provides low air-loss pressure management therapy, pulsation, percussion, Turn Assist. flexible patient positioning capabilities and built-in scales for patients weighing 300 Ib* to 850 Ib ([136*-386 kg] including accessories)
| Date | Sep 27, 2012 (initiated Sep 17, 2012) |
| Status | Terminated |
| Reason | KCI has issued a medical device correction for the BariAir Therapy System Hand Pendent. The BariAir Therapy System is not designed to allow the patient to place the bed into the patient exit position. KCI has received complaints indicating that patients used the hand pendent to inadvertently place the BariAir Therapy System into a pseudo-exit position. In a small number of instances, this allow |
| Root cause | Device Design |
| Action | KCI sent an Urgent - Voluntary Medical Device Correction letter dated September 13, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers would be contacted by KCI to coordinate a shipment of a replacement product. For questions customers would instructed to call 1-800-275-4524, Select Option 3 followed by Option 2. For questions regarding this recall call 1-800-275-4524. |
| Quantity | 575 |
| Distribution | Worldwide Distribution - USA (nationwide) and the countries of Saudi Arabia, United Kingdom, Singapore, Germany, Switzerland, Kuwait, United Arabian Emirates, and Austria. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.